NCT07021573尚未招募不适用
Protoporphyrin Imaging in Multispectral Evaluation of Resections
Medical University Innsbruck10 个研究点 分布在 3 个国家目标入组 80 人开始时间: 2025年9月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- Primary objective
研究概览
简要总结
Observational non-interventional investigation to evaluate the potential of multispectral imaging in improving tumor visualization.
详细描述
The clinical study is conducted in the post-market stage according to ISO 14155 Annex I.1 as it is performed with a CE marked microscope system. An additional component (CALLAO) will be added to the microscope. The intended use of the microscope as well as the surgical procedure remain unchanged by this addition. CALLAO allows for taking pictures of the situs in the OR which increases the surgery duration by <1min per picture. Therefore, this is a non-interventional study with a minimal burden to subjects.
The clinical investigation is not for a conformity assessment purpose. The burden to subjects is non-interventional.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age Requirement: Patients must be 18 years of age or older.
- •Diagnosis: Patients with a preoperative diagnosis of a suspected high-grade glioma based demographics and MRI imaging.
- •MRI Findings: Patients must meet one of the following criteria:
- •Group 1: Suspected high-grade glioma with contrast enhancement on MRI (GBM-like).
- •Group 2: Suspected high-grade glioma without contrast enhancement on MRI (LGG-like).
- •Surgical Resection: Patients scheduled to undergo surgical resection of the tumor as part of standard treatment.
- •5-ALA Administration: Patients who will receive 5-aminolevulinic acid (5-ALA) for fluorescence guidance during surgery.
- •Post-op MRI: Patients who are able to undergo pre- and postoperative MRI (standard of care at the center).
- •Informed Consent: Patients who are able to understand and provide written informed consent prior to enrollment in the study.
- •Eligibility for Multispectral Imaging: Patients whose surgical procedures allow for the use of multispectral imaging technology for tumor visualization.
- •Performance Status: Patients with a Karnofsky Performance Status (KPS) of 60 or greater, indicating that they are capable of at least limited self-care.
- •No Prior Treatment: Patients who have not received prior treatment for the current brain tumor, including surgery, radiotherapy, or chemotherapy.
排除标准
- •Patients with a known allergy or contraindication to 5-aminolevulinic acid (5-ALA) or its components.
- •Use of all other fluorescent markers.
- •Patients with a history of porphyria or other disorders related to 5-ALA metabolism.
- •Patients with recurrent gliomas or those who have received prior treatment for their current brain tumor, including surgery, radiotherapy, or chemotherapy.
- •Pregnant or breastfeeding patients, due to potential risks associated with 5-ALA administration.
- •Patients with severe comorbidities or other medical conditions that, in the investigator's opinion, would pose an unacceptable risk or compromise the safety of participation in the study.
- •Patients with a Karnofsky Performance Status (KPS) below 60, indicating an inability to perform minimal self-care.
- •Patients with a history of severe hepatic or renal impairment that may impact the metabolism of 5-ALA.
- •Patients unable to undergo MRI imaging for any reason (e.g., presence of non-MRI-compatible implants).
- •Patients unable to provide written informed consent due to cognitive, language, or other barriers.
- •Patients with tumors located in regions where fluorescence imaging is not technically feasible or where the use of multispectral imaging could interfere with the standard surgical approach.
- •Pregnancy
结局指标
主要结局
Primary objective
时间窗: 12 months
Detection of Tumor cells and fluorescence in biopsied tissue
次要结局
- Secondary objectives(12 months)
研究者
研究点 (10)
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